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Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
omega-3 fatty acid
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: At increased risk of developing breast cancer, as defined by 1 of the following criteria: 5-year Gail risk ≥ 1.7% Calculated 5-year Gail risk ≥ 5 times the average for age group, as defined by 1 of the following: At least 0.1% (for patients age 20-29) At least 1.0% (for patients age 30-39) At least 1.7% (for patients age 40 and over) Known BRCA1 or BRCA2 mutation carrier Family history consistent with hereditary breast cancer, as defined by any of the following: At least 4 relatives diagnosed with breast cancer at any age At least 2 first-degree relatives diagnosed with breast cancer at age 50 or younger Breast and ovarian cancer diagnosed in the same relative At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer at any age in the same family Atypical hyperplasia or lobular carcinoma in situ of the breast by prior biopsy History of unilateral ductal carcinoma in situ of the breast History of invasive stage I breast cancer in remission (completed local and systemic standard therapy) History of ovarian cancer in remission for > 5 years Baseline mammogram performed within the past 6 months with an interpretation of not suspicious for malignancy (BIRAD 1-3) Not eligible for OR refused standard breast cancer risk reduction strategies (e.g., prophylactic oophorectomy, prophylactic mastectomy, or tamoxifen) PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Not specified Performance status SWOG 0-1 Life expectancy Not specified Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Bilirubin ≤ 2.0 times ULN Renal Creatinine ≤ 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test No underlying medical, psychiatric, or social condition that would preclude study participation No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy More than 6 months since prior and no concurrent hormonal therapy, including any of the following: Antiestrogens Estrogen Selective estrogen-receptor modulators Progestins Aromatase inhibitors Hormonal contraceptives Radiotherapy Not specified Surgery No prior bilateral mastectomy Other More than 3 months since prior and no concurrent chronic (i.e., > 3 times per week) non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen, or indomethacin) or cyclooxygenase-2 inhibitors No prior cancer treatment that would preclude study treatment

Sites / Locations

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

Outcomes

Primary Outcome Measures

Breast density as measured by the Madena method at 1 year

Secondary Outcome Measures

Full Information

First Posted
June 13, 2005
Last Updated
September 16, 2013
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00114296
Brief Title
Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer
Official Title
A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Chemoprevention is the use of certain drugs or supplements to keep cancer from forming, growing, or coming back. The use of omega-3 fatty acids may prevent breast cancer. PURPOSE: This randomized clinical trial is studying how well omega-3 fatty acids work in preventing breast cancer in women at high risk of developing breast cancer.
Detailed Description
OBJECTIVES: Primary Determine the effects of omega-3 fatty acids on mammographic breast density (MBD) in women at high risk of developing breast cancer. Secondary Determine, preliminarily, the effects of this supplement on cell atypia and breast cell proliferation measured in ductal lavage specimens from these patients. Determine the effects of this supplement on circulating hormone and growth factor blood levels in these patients. Determine the effects of this supplement on the expression of estrogen-related proteins found in ductal lavage specimens from these patients. Determine the effects of this supplement on plasma lipid peroxidation levels in these patients. Correlate the modifying effect of lipid peroxidation-related genes with MBD in patients treated with this supplement. OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral placebo three times daily for 12 months. Arm II: Patients receive oral omega-3 fatty acids three times daily for 12 months. In both arms, treatment continues in the absence of the development of ductal carcinoma in situ or invasive carcinoma of the breast or unacceptable toxicity. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 fatty acid
Primary Outcome Measure Information:
Title
Breast density as measured by the Madena method at 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: At increased risk of developing breast cancer, as defined by 1 of the following criteria: 5-year Gail risk ≥ 1.7% Calculated 5-year Gail risk ≥ 5 times the average for age group, as defined by 1 of the following: At least 0.1% (for patients age 20-29) At least 1.0% (for patients age 30-39) At least 1.7% (for patients age 40 and over) Known BRCA1 or BRCA2 mutation carrier Family history consistent with hereditary breast cancer, as defined by any of the following: At least 4 relatives diagnosed with breast cancer at any age At least 2 first-degree relatives diagnosed with breast cancer at age 50 or younger Breast and ovarian cancer diagnosed in the same relative At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer at any age in the same family Atypical hyperplasia or lobular carcinoma in situ of the breast by prior biopsy History of unilateral ductal carcinoma in situ of the breast History of invasive stage I breast cancer in remission (completed local and systemic standard therapy) History of ovarian cancer in remission for > 5 years Baseline mammogram performed within the past 6 months with an interpretation of not suspicious for malignancy (BIRAD 1-3) Not eligible for OR refused standard breast cancer risk reduction strategies (e.g., prophylactic oophorectomy, prophylactic mastectomy, or tamoxifen) PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Not specified Performance status SWOG 0-1 Life expectancy Not specified Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL Hepatic SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times ULN Bilirubin ≤ 2.0 times ULN Renal Creatinine ≤ 2.0 mg/dL Other Not pregnant or nursing Negative pregnancy test No underlying medical, psychiatric, or social condition that would preclude study participation No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy More than 6 months since prior and no concurrent hormonal therapy, including any of the following: Antiestrogens Estrogen Selective estrogen-receptor modulators Progestins Aromatase inhibitors Hormonal contraceptives Radiotherapy Not specified Surgery No prior bilateral mastectomy Other More than 3 months since prior and no concurrent chronic (i.e., > 3 times per week) non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen, or indomethacin) or cyclooxygenase-2 inhibitors No prior cancer treatment that would preclude study treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustin Garcia, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

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Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer

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